Global Clinical Validation for Medical Devices & SaMD

CDSCO-Approved & ISO 14155 Well-Trained CRO - Fully compliant with ICH-GCP, US FDA 21 CFR 812, & EU MDR.


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Global regulatory bodies demand clinical data that withstands intense scrutiny. Operating from India, our premium CRO serves as your international clinical evidence hub-delivering regulatory-grade clinical investigation data built on strict scientific frameworks. We focus entirely on universally accepted clinical safety, performance, and usability endpoints to satisfy the harmonized requirements of the US FDA, EMA, and CDSCO.

Our Core Pillars of Strategy & Clinical Expertise

Pillar 1
Product Development, Usability Evaluation & Algorithm Training
Pillar 2
Global Regulatory Approval & Confirmatory Investigations
Pillar 3
Real-World Evidence & Market Expansion
Pillar 4
Post-Market Lifecycle Management

Build your technology on high-integrity data assets. We secure the foundational clinical datasets and human factors evidence needed to develop, optimize, and validate Medical devices, SaMD solutions, and AI-driven technologies before design freeze and regulatory submission.

  • Data Collection StudiesLarge-scale prospective and retrospective extraction of standardized clinical data (DICOM images, physiological signals, laboratory data, electronic health records, and real-world datasets) to train, test, and validate machine learning algorithms, software models, and device performance.
  • Academic & Investigator-Initiated StudiesEarly-stage collaborations with leading researchers and healthcare institutions to generate clinical insights, establish proof-of-concept evidence, and support peer-reviewed scientific publications.
  • Feasibility, Pilot & Usability StudiesAgile, small-scale investigations conducted in premier medical institutions to evaluate initial device safety, operational feasibility, workflow integration, and user acceptance. These studies include formative and summative usability evaluations, human factors assessments, task-based performance testing, use-error analysis, and user-interface validation to optimize product design and demonstrate safe and effective use by intended users.
For Indian MedTech StartupsFor Global Medical Device Companies

Why Partner With Us?

Flawless International Acceptance

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Operating strictly under ICH-GCP and ISO 14155 principles, our studies are designed to align with US FDA 21 CFR 812, EU MDR requirements, and CDSCO expectations, ensuring audit-ready clinical evidence.

India’s Diverse Patient Population

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Access a vast, multi-demographic, treatment-naïve patient population that enables accelerated recruitment and generation of clinically robust datasets reflecting broad real-world variability.

Scientific & Data Excellence

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Advanced Clinical Data Management Systems (CDMS), risk-based monitoring methodologies, validated electronic systems, and expert biostatistical support ensure exceptional data quality, integrity, and traceability.

Unified Lifecycle Management

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A single strategic partner supporting the entire clinical evidence journey—from protocol development and ethics committee approvals to site management, data analysis, clinical investigation reports, and post-market evidence generation.

Dedicated Expertise in Medical Devices & Digital Health

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Specialized experience across Medical Devices, Software as a Medical Device (SaMD), AI-enabled technologies, connected health solutions, and human factors engineering studies, ensuring clinically relevant and regulator-ready evidence generation.

Frequently Asked Questions

Which class of Medical Devices require clinical investigation in India?

Medical device clinical investigation is required in India to examine all Medical Devices / in vitro diagnostic kits class A, B, C, and D; if the medical device falls within the scope of an investigational medical instrument that doesn't have a predicate, is made in India or if its a new Medical Device / in vitro diagnostic kits.

Each individual, sponsor, clinical researcher, organization, and any other investigator participating in a clinical inquiry or his agent who has permission to do so shall keep the data, record, registers, etc., for seven years from the end of the clinical investigation. The Central Licensing Authority and any other authorized officers may require such information.

Clinical investigation of medical products is the process of obtaining data to evaluate the safety and performance of medical products in their intended use. This medical device performance study includes any side effects or risks the product may cause during its use.

Form MD 22 is an application to get the grant of permission to conduct clinical investigation of medical devices without predicate devices or new ones.

A “clinical investigation plan” is a document that describes the reasons, objectives, design methodology, monitoring, and statistical considerations. It also includes the proposed analysis, monitoring, conduct, and record-keeping for the clinical investigation.

Pilot studies for medical device clinical studies or drug development are typically performed as a priority at the beginning of the process. They can be conducted when little or no clinical experience is available with the device or drug. Pilot studies refer to medical devices or drug clinical trials that gather specific essential information about a device or drug before starting the pivotal trial. These trials will be used to make precise claims about safety and efficacy. A pivotal study for a medical device is a clinical test that attempts to show the efficacy of a new medical device, and it can be used to gain marketing approval from the regulatory authority. A medical device pivotal clinical study aims to demonstrate that a novel experimental medical device is more efficient than an existing standard-of-care medical device.

The Central Licensing Authority can, if satisfied with the application, grant permission to conduct a medical device clinical investigation in Form MD 23.

Any medical device or new in vitro diagnostic medical device imported or manufactured, for the purpose of clinical investigation or clinical performance evaluation, test, evaluation, demonstration and training, shall be kept in containers bearing labels, indicating the name of the product or code number, batch or lot number, serial number wherever applicable, date of manufacture, use before date, storage conditions, name and address of the manufacturer, and the purpose for which it has been manufactured.

The license pertaining to the import for test, evaluation, clinical investigations is granted using form MD-17 by the Central Licensing Authority.

The results of medical device or in-vitro diagnostic kit clinical investigation may not be required to be submitted where the investigational medical device is approved by the regulatory authorities of either the United Kingdom or the United States of America or Australia or Canada or Japan or EU and the said device has been marketed for at least two years in that country and the Central Licencing Authority is satisfied with the data of safety, performance and pharmacovigilance of the device.


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